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This is an ongoing theory of the Food and Drug Administration (FDA) in the e-cigarette community: The agency did not expect it to receive more than 6 million pre-market tobacco product applications (PMTA) before the September 2020 deadline. And find a way to sort them all by the next year. This is no easy task, but the threshold for authorization will be very high-in the FDA's view, it will help.

From the perspective of this criticized institution, the documents obtained by Filter show how this vague process is presented. They also showed for the first time from the agency itself other content that the e-cigarette community has long inferred: Despite some protests to the contrary, the FDA has taken a systematic and different approach to PMTA applications for flavored products that so many previous smokers have relied on .

The agency has previously stated that the threshold to be reached-"fit to protect public health"-will largely involve a tricky balancing act. Reviewers at the FDA's Center for Tobacco Products (CTP) will weigh the potential of specific products to promote adult smokers to switch to safer alternatives against their potential to attract a new generation of nicotine users.

The FDA also made it clear that—even though many in the industry thought it did so after the September 2020 submission deadline—a tilt toward authorization may require one of at least two types of research: longitudinal cohort studies, large tracking Large-scale long-term populations, or Randomized Controlled Trials (RCT), another type of research that examines specific populations through time intervals. Both are expensive and require high-level skills.

However, on September 9, Mitch Zeller stated in the agency’s PMTA process update that the FDA “does not rule out the possibility that other types of evidence may be sufficient if it is sufficiently strong and reliable.” But the The agency has never really expanded other types of evidence.

The FDA memorandum reviewed by Filter provides an internal investigation of the procedure and clearly stipulates how the agency handles applications for a large number of flavored e-cigarette products.

"The [Science Office] will conduct a fatal defect review for non-tobacco-flavored ENDS products that are not in the third phase of PMTA."

"The mission of the Office of Science is to develop a new plan to effectively manage the remaining non-tobacco flavor ENDS PMTA that has not entered the third phase of substantive scientific review," CTP Office Director Matthew Holman wrote in a memorandum signed on July 9. science. “In view of the possible impact on the market on September 10, 2021, which is deemed to be the end of the enforcement discretionary period for tobacco products, and in order to take final action on as many applications as possible before September, the Acting Commissioner has allocated this Mission October 2021."

"Considering that there are still a large number of applications to be reviewed before the September 9, 2021 deadline, OS [Science Office] will conduct a fatal defect review for non-tobacco-flavored ENDS products that are not in the third phase of PMTA," the memorandum continued. "The fatal flaw review is a simple review in which the examiner checks the submitted document to determine whether it contains the necessary type of research."

Importantly, the memo continues: “The fatal flaw review will be limited to determining the existence of such research; it will not assess the value of the research.”

According to the FDA, the PMTA review is divided into three “phases”: the first phase (acceptance), which basically means that the application has been received; the second phase (notification or filing), which requires the recognition that the company has sufficient information to Formally submit its application; the third stage (review) includes a substantive scientific evaluation, followed by a marketing authorization order (MGO) or MDO. (In August, the agency refused to submit—that is, to enter the second stage—about 4.5 million vapor product applications submitted by a single manufacturer, JD Nova, because environmental assessments were not included.)

The memo went on to explain that CTP used "database queries to identify the top 12 manufacturers with the largest number of pending PMTAs that are not in the third phase of non-tobacco-flavored e-liquid products", accounting for 85% of all pending PMTA applications. The agency "withdraws these applications from their respective positions in the PMTA priority list", and once they "launch the second phase application", they will be subject to "fatal defect" review.

A former CTP employee said that they had not heard of the "fatal defect" standard until now. 

"The manufacturer is responsible for presenting their reasons in their application," Eric Lindblom, a senior scholar at the Georgetown O'Neill National and Global Health Law Institute and former director of the CTP Policy Office, told the filter. "Moreover, the FDA has no legal obligation to fill in any missing gaps or apply external research or evidence to make the application meet the application requirements...make the application worthy of an order that allows marketing-make the marketing of PMTA products suitable for protecting public health."

Nevertheless, the fatal flaw standard seems to be new. CTP didn't seem to use it in the past. A former CTP employee who asked not to be named told Filter that they had not heard of the "fatal defect" standard until now.

The FDA rejected the applications of most small and medium-sized manufacturers, issued the same marketing denial order (MDO) for their main flavored products, and stated that more time is needed to evaluate the participants with the largest market share. (It only authorized one type of e-cigarette and two types of tobacco-flavored cartridges.)

As a result, the way what was previously shrouded in mystery happened has become clearer: CTP reviewers have created a potentially new way to solve the backlog of millions of PMTAs, without evaluating any other evidence These applications were searched for longitudinal cohort studies and RCTs. For applications that lacked them, they were not advanced to the second stage, and only templated MDOs were sent.

"The'fatal defect' standard was formulated by the acting commissioner out of embarrassment towards Hill."

Some in the steam industry doubted whether the "fatal flaw" review came after the agency's acting commissioner Janet Woodcock testified at a congressional hearing at the end of June. Many leading Democrats-including the two most outspoken e-cigarette critics, Senator Dick Durbin and Congressman Raja Krishnamoorthi-blame Woodcock and her agency for not doing enough to address the e-cigarette rate among young people . In other words, even if young people’s e-cigarettes have fallen, there may still be political pressure to take action. Holman signed the memorandum two weeks after the hearing.

An industry insider who asked not to be named told Filter: "The'fatal defect' criterion was formulated by the acting commissioner out of embarrassment towards Hill."

"Janet Woodcock's legacy will not be vaccines or drug approvals," they continued. "This will make her politically involved in the e-cigarette market and make it harder for the products adults use to quit smoking to stay on the market. So far, she has politicized the FDA more than any of her recent predecessors."

The FDA declined to comment through a spokesperson because the agency will not comment "on possible, pending or ongoing litigation."

At the same time, dozens of steam companies sued the FDA, mainly for "arbitrary and capricious" behavior. Two of the companies have now been completely withdrawn. The agency cited "the FDA found that the relevant information was not fully evaluated."

Another company, Triton, received a full suspension from the Federal Court of Appeals at the end of October, and continued to sell its products after its lawsuit passed the court system. The company revealed that at least some judges agreed with the industry’s logic: FDA did not adequately inform manufacturers to vertical Long-term data in the form of cohort studies or RCTs are absolutely necessary.

The new evidence of the FDA's cut and paste method that emerged through these lawsuits further confirmed the e-cigarette proponents' description of this process, which is not only confusing, but also contrary to small companies and tastes.

Photographed by Penn State University via Flickr/Creative Commons 2.0

Alex is a contributing writer for Filter. He previously worked as a reporter and copy editor at VICE, and has published articles in the New York Times Magazine, Columbia News Review, The Nation, and The Daily Beast. He is also a freelance editorial consultant for the Smokeless World Foundation; the Impact of Operating Filter Foundation has received limited and general support grants from the Smokeless World Foundation. Alex is currently working in Phoenix, Arizona.

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